Cleared Traditional

K841566 - HESUNG DISPOSABLE SYRINGE

K841566 is the FDA 510(k) clearance for HESUNG DISPOSABLE SYRINGE by Amkor Trading Co.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K841566 · Amkor Trading Co. · General Hospital
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Jul 1984
Decision
91d
Days
Class 2
Risk

K841566 is an FDA 510(k) clearance for the HESUNG DISPOSABLE SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Amkor Trading Co. (Mchenry, US). The FDA issued a Cleared decision on July 17, 1984 after a review of 91 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Amkor Trading Co. devices

Submission Details

510(k) Number K841566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1984
Decision Date July 17, 1984
Days to Decision 91 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 129d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 303
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K841566.
MONOJECT STERILE 1/2 CC & 1CC SYRINGES W & W/O NEE
K851090 · Sherwood Medical Co. · Apr 1985
BLOOD GAS SAMPLER KIT
K850958 · Churchill Corp. · Apr 1985
SYRINGE W/NEEDLE COMBIN & SYRINGE ONLY
K844106 · Abco Dealers, Inc. · Jan 1985
FLUID REMOVAL ASSEMBLY
K840490 · Ackrad Laboratories · Apr 1984
HYPODERMIC SYRINGES & NEEDLES
K834548 · Cordis Corp. · Mar 1984
SYRINGE
K833399 · I M, Inc. · Jan 1984